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Purpose of Review: With cochlear implantation becoming increasingly performed worldwide, an understanding of the risk factors, preventive measures, and management of cochlear implant (CI) infection remains important given the significant morbidity and cost it conveys., Recent Findings: At the turn of the 21st century there was a decrease in rates of CI infection, particularly meningitis, following the discontinuation of positioner use for CI. However, in more recent years rates of CI infection have remained largely static. Recently, studies evaluating preventive measures such as pneumococcal vaccination, S. aureus decolonization and surgical antibiotic prophylaxis have emerged in the literature., Summary: Prompt recognition of CI infection and appropriate investigation and management are key, however at present treatment is largely informed by cohort and case-control studies and expert opinion. Preventive measures including pneumococcal vaccination, S. aureus decolonization and preoperative antibiotic prophylaxis play a role in reducing rates of CI infection. However, there remains a need for well designed clinical trials to provide higher level evidence to better guide preventive measures for, and management decisions of, CI infections in the future., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: This study aims to assess the frequency, bacteriology, biofilm characteristics and management of skin flap infection (SFI) following cochlear implantation (CI)., Methods: The study enrolled 1,251 patients receiving CI in the First Affiliated Hospital of Fujian Medical University between August 2001 and March 2021. Scanning electron microscopy (SEM) was utilised to characterise the aetiology of infection. A proposed classification system was applied to optimise treatments for post-operative skin flap infection., Results: After CI, SFI was reported in 16 patients (1.28%) and occurred more frequently in patients under 6 years of age. Of all SFI cases Staphylococcus aureus was the most common pathogen for flap infection, with 8 cases (50%) and bacterial biofilm was evident within the jelly-like substance on the surface of implanted devices in SFI patients. A two-stage classification was proposed to optimise the treatment schemes. Conservative therapy was recommended for stage I cases and surgical treatment for stage II patients., Conclusions: Paediatric patients are more susceptible to SFI after CI, which may be attributed to the formation of bacterial biofilm. The proposed classification can facilitate the management of SFI., (Copyright © 2022 Società Italiana di Otorinolaringoiatria e Chirurgia Cervico-Facciale, Rome, Italy.)

Within this study, new materials were synthesized and characterized based on polysiloxane modified with different ratios of N -acetyl-l-cysteine (NAC) and crosslinked via UV-assisted thiol-ene addition, in order to obtain efficient membranes able to resist bacterial adherence and biofilm formation. These membranes were subjected to in vitro testing for microbial adherence against S. pneumoniae using standardized tests. WISTAR rats were implanted for 4 weeks with crosslinked siloxane samples without and with NAC. A set of physical characterization methods was employed to assess the chemical structure and morphological aspects of the new synthetized materials before and after contact with the microbiological medium.

Although negative pressure wound therapy (NPWT) is widely used, its application to the head and neck region remains challenging due to anatomical complexities. This report presents the case of a female patient presenting with mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes, uncontrolled diabetes and severe bilateral sensorineural hearing loss. The patient had undergone cochlear implant surgery and five months later the wound was infected with methicillin-resistant Staphylococcus aureus (MRSA). NPWT was started shortly after removing the internal receiver and was stopped 11 days later. NPWT helped in controlling infection and led to a successful wound closure. In this case, NPWT was effective in treating infectious wounds around the auricle after cochlear implant surgery. Declaration of interest: The authors have no financial support for this article and no conflict of interest directly relevant to the content of this article.

The capability of Pseudomonas aeruginosa and Staphylococcus aureus to form biofilm on varying CI component materials differs in the presence and absence of bioactive glass (BAG). The application of BAG induces significant changes in biofilm morphology which can be visualized via scanning electron microscopy (SEM). Bacterial biofilm formation on medical devices, such as cochlear implants (CI), can lead to chronic infections. Interestingly, BAG of type S53P4 seems to be a promising tool for use in the reduction of biofilm development. Primarily, four bacterial species known to cause implant-related infections, P.aeruginosa (ATCC9027), S. aureus (ATCC6538), Staphylococcus epidermidis (ATCC12228) and Streptococcus pyogenes (ATCC19615) were analyzed regarding their capacity to form biofilm on CI components manufactured from three kinds of material: silicone, platinum and titanium. Subsequently, P. aeruginosa and S. aureus biofilms were visualized using scanning electron microscopy, comparing BAG-treated biofilm with non-treated biofilm. The four bacterial species presented biofilm-forming capabilities in a species and surface dependent manner. Metal CI components allowed for the greatest proliferation of biofilm. S. aureus and P. aeruginosa showed the highest rate of biofilm formation on polystyrene surfaces. For both species, SEM revealed altered biofilm morphology after treatment of S53P4 BAG. This study indicates that bacterial biofilm formation and structure on CI components is dependent on the surface composition, altering between metal and silicone surfaces. After application of BAG, changes in biofilm morphology on CI components were observed. These data highlight the impact of BAG on bacterial biofilm morphology., Competing Interests: The study was conducted with materials supplied by the following companies (named alphabetically): Advanced Bionics, BonAlive®, Cochlear™, MED-EL. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Hypothesis: Biofilm formation on cochlear implant (CI) surfaces differs between bacterial species and can be reduced by the application of S53P4 bioactive glass., Background: The formation of bacterial biofilms on medical devices, such as cochlear implants, can lead to chronic infections resulting in the need for implant removal. In this study, various surfaces of three CI implant kits from different manufacturers were examined for bacterial biofilm formation and reduction of a pre-existing biofilm by the application of bioactive glass., Methods: Biofilm formations of 4 bacterial species causing implant-related infections were tested on 17 different surfaces: Pseudomonas aeruginosa (ATCC9027), Staphylococcus aureus (ATCC6538), Staphylococcus epidermidis (ATCC12228), and Streptococcus pyogenes (ATCC19615). For P. aeruginosa and S. aureus biofilm reduction after application of S53P4 bioactive glass was evaluated., Results: All tested microbial species formed biofilms on the examined CI surfaces in a strain-dependent manner. For S. aureus, a significantly higher biofilm formation on metal components compared with silicone was found whereas the other strains did not show a material specific biofilm formation. Application of S53P4 bioactive glass resulted in a significant reduction of P. aeruginosa and S. aureus mature biofilm., Conclusion: The four bacteria species displayed biofilm formation on the CI surfaces in a species- and material-specific manner. The results show that bioactive glass can reduce biofilm formation on CI materials in vitro. Future studies are necessary to confirm the results in vivo.

BACKGROUND Streptococcus pneumoniae can cause life-threatening illness, with invasive pneumococcal diseases (IPD) like meningitis, sepsis, bacteremic pneumonia, and bacteremia being major causes of morbidity and mortality. Studies have shown that patients who have had a cochlear implant, particularly children, have an increased risk of bacterial (pneumococcal) meningitis. Vaccination in patients with cochlear implants is important and recommended universally. The World Health Organization recommends the use of pneumococcal conjugate vaccines in all countries and considers their use to be a priority in all national immunization programs. The objective of this study was to assess rates of vaccination against Streptococcus pneumoniae in patients with cochlear implants who were implanted at the Institute of Physiology and Pathology of Hearing, Poland. MATERIAL AND METHODS We analyzed data from questionnaires administered to 2,628 patients who visited the Implants and Auditory Perception Department (IAPD) of the Institute of Physiology and Pathology of Hearing between January 2014 and March 2016. RESULTS The percentage of vaccinated patients in the study group was 28.2%, most of whom (90.7%) were children. Among the children, 49.3% were vaccinated against S. pneumoniae, but the corresponding rate for adults was only 5.5%. CONCLUSIONS The percentage of patients with cochlear implants who received vaccination against S. pneumoniae was low, both in children and adults, but especially in adults comparing to available reports.

Objectives Cochlear implant infections may be refractory to medical management and require device removal with subsequent reimplantation. During device removal, the intracochlear electrode array is commonly left in place to prevent obliteration of the cochlear lumen. If the electrode is colonized with pathogens, this risks contaminating the replacement implant. In this study, we compare the microorganisms detected on infected cochlear implants against those on the retained electrode using culture and microbial gene-sequencing techniques. Study Design Prospective single-cohort study. Setting Tertiary medical center. Subjects and Methods Six patients with refractory cochlear implant infections had the receiver-stimulator and extracochlear electrode removed to facilitate treatment of the infection. The intracochlear electrode was removed at (delayed) reimplantation. Implant specimens were analyzed by microbial culture and 16S DNA gene sequencing. Results Staphylococcus aureus was the organism most commonly identified. None of the 6 patients' intracochlear electrodes yielded microbes by culture. Two intracochlear electrodes revealed bacterial species, and 1 revealed fungal species by gene sequencing. There was no correlation between the microbes on the infected extracochlear implants and the retained intracochlear electrodes. All subjects underwent reimplantation after resolution of their infections. One of 6 subjects developed a second infection after reimplantation, with S aureus in the primary and secondary infections. Conclusions The intracochlear electrodes of infected cochlear implants carry a low microbial burden. Preserving intracochlear electrodes upon removal of infected cochlear implants appears to carry a low risk of contaminating a replacement cochlear implant.

Objective: Chronic, persistent infections complicate otologic procedures utilizing implantable devices such as cochlear implants or tympanostomy tubes. These infections are thought to be due to the establishment of microbial biofilms on implant surfaces. To address this issue, we hypothesized that surface charge modification may inhibit the formation of Pseudomonas aeruginosa biofilms on implant surfaces in vitro and in vivo., Study Design: We evaluated the effect of surface charge modification on bacterial biofilm formation by assessing the effect of the surface charge on bacterial adhesion in vitro and bacterial persistence in vivo., Methods: To study the effect of surface charge in vitro, the surface wells in culture plates were modified using a layer-by-layer polyelectrolyte assembly method. Bacterial adherence was measured at 30-, 60-, and 120-minute intervals. To study the effect of surface charge modification in vivo, the surface of titanium microscrews was similarly modified and then surgically implanted into the dorsal calvaria of adult rats and inoculated with bacteria. Two weeks after implantation and inoculation, the number of bacteria remaining in vivo was evaluated., Results: Surface charge modification results in a significant decrease in adherence of bacteria in vitro. Surface charge modification of titanium microscrew implants also resulted in a significant decrease in P. aeruginosa recovered 2 weeks after surgical implantation., Conclusion: Charge modification decreases the number of bacteria adherent to a surface in vitro and decreases the risk and severity of implant infection in an in vivo rat infection model. These results have promising biomedical applications., Level of Evidence: NA. Laryngoscope, 127:1655-1661, 2017., (© 2016 The American Laryngological, Rhinological and Otological Society, Inc.)

Objective and Importance: Preoperative chronic otitis media (COM) is a risk factor for postoperative infection after cochlear implantation (CI), but its management varies by surgeon. Our case highlights a strategy for implant preservation in a patient with a history of recurrent cochlear implant infection., Clinical Presentation: A 70-year-old woman with a history of chronic lymphocytic leukemia presented in 2005 with bilateral COM and sensorineural hearing loss meeting CI candidacy. Four months after left mastoid obliteration with abdominal fat graft and external auditory canal closure, a left CI was placed. Subsequent postauricular cellulitis resolved with oral antibiotics. A similar two-stage CI was performed on the right without complication. During the following year, numerous left-sided infections and fluid collections developed but were treated unsuccessfully with intravenous (IV) antibiotics and operative debridement. With concern for biofilm colonization, the implant was explanted and the electrode left in the cochlea. After reimplantation in 2010, infections resumed despite long-term IV antibiotics and incision and drainage. Intervention and technique In 2012, the left mastoid cavity was exteriorized and converted to standard canal wall-down anatomy. Bone pâté was placed over the electrode, followed by cadaveric acellular dermis and a split-thickness skin graft. After more than 2 years, her better-performing CI remains infection-free., Conclusion: After 6 years of postoperative infections unresponsive to aggressive medical management, surgical interventions, and period of device removal, our patient's infections resolved after mastoid exteriorization and multilayered protection of the electrode. This strategy may enable implant preservation in patients with recurrent post-CI infection in an obliterated cavity.

The purpose of the study is to assess the effect of a novel quorum sensing inhibitor (QSI), coded as 'yd 47', against otitis media and biofilm formation on Cochlear implants (CIs). Small pieces cut from cochlear implant were implanted under the skin in the retroauricular area on both sides of four guinea pigs. The implant pieces in the study and control sides were implanted in Streptococcus pneumoniae strain solution and saline, respectively. The right and left middle ears were also instilled with a solution containing pneumococci and saline, respectively. The animals were only given an intraperitoneal 'yd 47' twice daily for three months to be assessed later with electron microscopy. Clinical examination with palpation, inspection and otoscopy did not reveal any sign of implant infection or otitis media. In the study and control implant materials, soft tissues around the implant and tympanic membranes, there was no biofilm formation by pneumococci. Contamination by various cells and some rod-shaped bacteria (not diplococcic) were seen in some of the materials. In conclusion, the novel QSI seems promising in the prevention of otitis media and biofilm formation on CIs by pneumococci.

Objective: A patient with a well-healed, functional cochlear implant (CI) experienced a CI and mastoid infection shortly after initiating large-volume nasal irrigations after sinus surgery. The goal of this report is to bring attention to a rare complication and to question if large-volume nasal irrigation is safe in CI recipients., Patients: Single patient at a tertiary care hospital., Interventions: A CI recipient began using large-volume nasal irrigations with saline and budesonide after undergoing sinus surgery., Main Outcome Measures: CI infection and mastoiditis., Results: Two weeks after starting nasal irrigations, the patient presented with mastoiditis and CI infection. Mastoid and intranasal middle meatal cultures both grew Group A streptococcus., Conclusion: Large-volume nasal irrigations may be related to our patient's CI infection, ultimately leading to explantation. Though a causal relationship cannot be definitively proven, awareness of this potential safety issue should be disseminated.

Objectives: To examine the efficiency of a bacteria-resistant coating for the polydimethylsiloxane (PDMS) casing of cochlear implants., Methods: The coatings are based on thin titania films that are made by liquid phase deposition or atomic layer deposition. The antibacterial activity of the coating was tested by two different detection assays: BCA protein and confocal microscopy., Results: Coating the PDMS with thin films (10-40 nm) of titania significantly reduces the accumulation of bacteria., Discussion: Thin oxide films made under conditions that do not undermine the integrity of polymeric materials can be used as anti-microbial coatings for soft polymers such as the PDMS that is used as a casing for cochlear implants or other medical devices.

Objective: Early treatment of profound bilateral sensorineural hearing loss with cochlear implantation has become routine, resulting in an increased proportion of children implanted at younger ages. These children are at a relatively high risk for acute otitis media (AOM), and are more likely to develop mastoiditis in the implanted ear. Despite the significant risks associated with mastoiditis, including compromise of the implant, there are no specific guidelines on the management of this population. We propose a treatment algorithm emphasizing early but conservative operative intervention., Methods: A retrospective chart review included eight patients, who experienced mastoiditis, in the context of cochlear implantation at our center from August 2005 to November 2012. During this period 806 implant surgeries were completed., Results: The median age at which mastoiditis occurred was 37 months, and the mean time from implantation to mastoiditis was 9.56 months. All patients underwent drainage of the middle ear in conjunction with intravenous antibiotics, and two additionally underwent post-auricular incision and drainage., Discussion: Recent mastoidectomy may be a risk factor for the development of a post-auricular abscess in children, who develop AOM following cochlear implantation. A treatment algorithm was developed, which emphasizes early operative drainage in conjunction with aggressive antibiotic therapy. Conclusions A consistent approach to the management of mastoiditis in children with cochlear implants has not been established. Rapid initiation of aggressive antibiotic therapy and a low threshold for conservative operative intervention results in effective resolution of infection while allowing preservation of the implant.

Objective: To describe the microbial flora associated with cochlear implants (CIs) removed for infectious and noninfectious indications., Study Design: Prospective, controlled., Setting: Academic, tertiary medical center., Patients: All patients undergoing CI removal., Intervention: CIs were removed with aseptic technique and processed for microbial identification., Main Outcome Measure: CI microbes were identified with routine culture and speciation and 16s deoxyribonucleic acid 454-pyrosequencing., Results: All CIs had evidence of microbes. Propionibacterium acnes and Acidovorax facilis were more common on noninfected CIs (p = 0.005, 0.031). Staphylococcus aureus was more common on infected CIs (p = 0.003). The microbial profiles associated with CI infection were different from, but overlapped with those of noninfected CIs. Microbial culture with selective media identified pathogens not identified on pyrosequencing., Conclusion: Bacteria are present on all CIs, both with and without evidence of clinical infection, but species differ with clinical status. Empiric therapy for CI infections should include coverage for S. aureus. Gene pyrosequencing and selective culture techniques may yield complementary results that may impact the management of CI infections.

Objective: To investigate the presence and spectrum of bacterial colonization in relation to cochlear implant infections by introducing molecular biologic methods., Method: In a pilot test, a virgin device served as a control to validate the subsequent sampling and analysis process via PCR and SSCP. Subsequently, analysis was performed on specimens of 15 cochlear implants explanted from 15 patients because of device failures, infections, or malinsertions., Results: Positive SSCP results could be verified on 8 of the 15 explanted CI, in detail, 3 of 4 infected cochlear implants and 5 of 9 cochlear implants explanted because of device failure. The germ spectrum shows common germs such as Staphylococcus aureus, Pseudomonas aeruginosa, and Haemophilus influenzae, as well as germs from the dental cavity, with a peak of P. aeruginosa in infections., Conclusion: Detection and identification of microbial colonization on cochlear implants can be successfully conducted using the proposed approach of smear test subsequent genetic analysis. The prevalence of P. aeruginosa and germs from the dental cavity may demand an adaption of antibiosis with respect to these germs. Further investigations of the path of infection are needed, and patients might require a prevention by preoperative dental treatment.

One of the most dreaded complications after cochlear implantation is infection. These infections are a challenge due to lack of any data regarding optimal methods of investigation and management. More often than not, these patients have to undergo explantation and revision surgery. This paper presents a case report and literature review which focuses on the role of antibiotics and the need for early explantation in most biofilm-related infections of cochlear implants.

Relevance: Biofilm forming microorganisms are responsible for the infection of a number of different indwelling medical devices including cochlear implants. The current definitive technique for proving biofilm infection is the use of scanning electron microscopy that is expensive and of limited availability., Clinical Presentation: A persistently infected cochlear implant was explanted. At operation it was surrounded by a fibrous capsule containing a glue-like substance, characteristic of biofilm formation that yielded Staphylococcus aureus after ultrasonication of the device., Technique: The explanted cochlear implant was placed in a nutrient broth in an ultrasonic water bath. The implant was ultrasonicated for 5 minutes and the broth cultured on blood agar, incubated aerobically and anaerobically for 48 hours, and then incubated in air on Maconkey agar for 24 hours. This produced a heavy, confluent growth of S. aureus, in contrast to previous aspirates from a blister that lay over the infected implant that grew a coliform organism and Pseudomonas sp., Conclusion: Ultrasonication is a widely available and relatively inexpensive technique that can be used to improve the recovery of biofilm-associated organisms from explanted cochlear implants.

Understanding the issues of infection related to an implantable medical device is crucial to all cochlear implant teams. Furthermore, given the risk of central nervous system complications and the relatively high quantity of underlying resource investment associated with cochlear implantation, the stakes of infection are high. The optimal strategies to prevent and manage such infections are still evolving as good-quality prospective data to guide such management decisions are not yet abundant within the medical literature and many recommendations are based on retrospective reviews or anecdotal evidence. We will outline a general strategy to deal with cochlear implant-related infection based on both the authors' experience and the published literature.

Objective: Bacteria can grow as individual, planktonic organisms or as complex biofilm communities that are more resistant to treatment. This review was designed to systematically search to identify recent laboratory studies on eradication of biofilms in otolaryngologic infections to highlight promising advances in biofilm treatment., Data Sources: A systematic electronic literature search of Medline/PubMed, CINHAL, and Web of Science was conducted for articles describing the treatment of biofilm infections in ear, nose, and throat (ENT) diseases through March 2010. English-language articles and articles with an English abstract that focused on biofilm treatment were considered for review., Review Methods: Each included article was reviewed by one of the authors for study design, treatment intervention, and outcome. Data from in vitro and animal studies were considered separately from human studies., Results: A total of 30 articles were identified for this review, including 5 studies that included a human treatment component. In general, antibiotics were relatively ineffective for eradicating biofilm infections. Markedly higher antibiotic dosages were required to reduce biofilm presence compared with doses that were effective in eradicating planktonic bacteria. Mupirocin irrigation, gentian violet, and thiamphenicol glycinate acetylcysteine effectively eradicated biofilms. Physical disruption, surfactants, and probiotics were also shown to be beneficial in both nonhuman and human studies., Conclusion: Eradicating ENT biofilms is difficult when treating single-organism or mixed flora biofilms. Antibiotic therapy is often ineffective against biofilms, and clinical treatment may need to focus on nonantibiotic therapies that reduce, disrupt, or eradicate ENT biofilms.

Cochlear implants have been associated with increased risks of bacterial meningitis in children, notably but not limited to implants with a sialastic accessory piece called a positioner. Because of the associated risks, these devices were ultimately recalled by the Food and Drug Administration in 2002. We present a case of a fully immunized 4-year-old child with a cochlear implant without a positioner who developed Streptococcus pneumoniae meningitis 3 years after implantation. The case highlights the increased risk for bacterial meningitis in the presence of cochlear implants regardless of device type, immunization status, or time after implantation especially in the context of middle- and inner-ear structural anomalies.

Objective: To provide recommendations for 1) prevention of acute otitis media and meningitis via immunization and 2) antimicrobial therapy of acute otitis media and meningitis in children with cochlear implants., Data Sources: Literature review and policy statement from the American Academy of Pediatrics., Conclusion: 1) Children who are candidates for cochlear implants or have received cochlear implants should receive all-age appropriate vaccinations, including indicated doses of 13-valent pneumococcal conjugate vaccine, Haemophilus influenzae type b conjugate vaccine, and influenza vaccine. A supplemental dose of 13-valent pneumococcal conjugate vaccine is indicated for children who have received indicated doses of 7-valent pneumococcal vaccine, but have not received 13-valent pneumococcal conjugate vaccine. In addition, children 24 months and older should receive a single dose of 23-valent pneumococcal polysaccharide vaccine. 2) Acute otitis media in children with cochlear implants should be treated with an antimicrobial. During the first 2 months after implant, initial treatment of acute otitis media with a parenteral antimicrobial, e.g., cetriaxone, is indicated. High-dose amoxicillin or amoxicillin-clavulanate is an appropriate antimicrobial choice for empiric treatment of acute otitis media occurring 2 or more months after implant. In cases of meningitis occurring during the first 2 months after implantation, broad spectrum empiric antimicrobial therapy, e.g., meropenem and vancomycin, should be initiated pending the results of CSF culture. Empiric antimicrobial therapy with ceftriaxone and vancomycin is appropriate for cases of meningitis occurring 2 or more months after implant.

Objective: To investigate the formation of bacterial biofilms on the surface of the electrode array of cochlear implants (CI) explanted because of device failure, without evidence of infection, by use of scanning electron microscopy (SEM) and confocal laser scanning microscopy (CLSM)., Study Design: Prospective study., Setting: Patients from 2 tertiary-care referral centers., Patients and Methods: CIs were explanted from 9 patients because of device failure. Specimens were immediately snap-frozen in cold isopenthane, stored at -80°C and examined with SEM and CLSM by 3 investigators., Main Outcome Measure: Presence of bacterial biofilm ascertained by SEM and CSLM., Results: One specimen showed the formation of a bacterial biofilm on the middle ear part of the electrode array. No biofilm formation was found in the inner-ear part of electrode arrays. In the middle-ear part of the electrode array, a cylindrical cover of human muscular tissue was seen plugging the cochleostomy., Conclusion: This is the first study demonstrating that bacterial biofilms may exist on the surface of the electrode array of CIs explanted because of device failure but not infection. We found 1 case of biofilm formation in 9 explanted CIs. Further studies with larger series of CIs are required to investigate biofilm formation on the surface of CI electrode arrays to address both the pathophysiology of bacterial biofilms and prevention of device-related infections in CI patients.

Meningitis after cochlear implantation continues to be a concern. Recent studies and anecdotal reports support the belief that intracochlear trauma, lack of appropriate immunizations, and a previously used dual-component electrode predispose patients to a higher rate of contracting meningitis. In addition, a history of meningitis, cochlear dysplasia, and certain variations of surgical technique such as the cochleostomy, very young age, immunocompromise, and the presence of neural prostheses such as shunts, are all potentially predisposing factors. Because many of these factors are beyond our control, there is likely to be an inevitable baseline incidence of meningitis, perhaps related to the underlying deafness, but by controlling other factors, we can hope to minimize the incidence. Despite the efforts of multiple individuals and organizations, there continue to be new cases of meningitis, including a small number of fatalities, each year. There is recent evidence that a sizeable percentage of children with implants have not been vaccinated as suggested by governmental agencies, otolaryngologic societies, implant manufacturers, and many cochlear implant centers. Clearly, efforts must be made to ensure age-appropriate vaccination for all cochlear implant recipients.

The use of cochlear implants is increasingly common, particularly in children younger than 3 years. Bacterial meningitis, often with associated acute otitis media, is more common in children with cochlear implants than in groups of control children. Children with profound deafness who are candidates for cochlear implants should receive all age-appropriate doses of pneumococcal conjugate and Haemophilus influenzae type b conjugate vaccines and appropriate annual immunization against influenza. In addition, starting at 24 months of age, a single dose of 23-valent pneumococcal polysaccharide vaccine should be administered. Before implant surgery, primary care providers and cochlear implant teams should ensure that immunizations are up-to-date, preferably with completion of indicated vaccines at least 2 weeks before implant surgery. Imaging of the temporal bone/inner ear should be performed before cochlear implantation in all children with congenital deafness and all patients with profound hearing impairment and a history of bacterial meningitis to identify those with inner-ear malformations/cerebrospinal fluid fistulas or ossification of the cochlea. During the initial months after cochlear implantation, the risk of complications of acute otitis media may be higher than during subsequent time periods. Therefore, it is recommended that acute otitis media diagnosed during the first 2 months after implantation be initially treated with a parenteral antibiotic (eg, ceftriaxone or cefotaxime). Episodes occurring 2 months or longer after implantation can be treated with a trial of an oral antimicrobial agent (eg, amoxicillin or amoxicillin/clavulanate at a dose of approximately 90 mg/kg per day of amoxicillin component), provided the child does not appear toxic and the implant does not have a spacer/positioner, a wedge that rests in the cochlea next to the electrodes present in certain implant models available between 1999 and 2002. "Watchful waiting" without antimicrobial therapy is inappropriate for children with implants with acute otitis media. If feasible, tympanocentesis should be performed for acute otitis media, and the material should be sent for culture, but performance of this procedure should not result in an undue delay in initiating antimicrobial therapy. For patients with suspected meningitis, cerebrospinal fluid as well as middle-ear fluid, if present, should be sent for culture. Empiric antimicrobial therapy for meningitis occurring within 2 months of implantation should include an agent with broad activity against Gram-negative bacilli (eg, meropenem) plus vancomycin. For meningitis occurring 2 months or longer after implantation, standard empiric antimicrobial therapy for meningitis (eg, ceftriaxone plus vancomycin) is indicated. For patients with meningitis, urgent evaluation by an otolaryngologist is indicated for consideration of imaging and surgical exploration.

Objective: This study aimed to investigate antimicrobial treatment of an infected cochlear implant, undertaken in an attempt to salvage the infected device., Methods: We used the broth microdilution method to assess the susceptibility of meticillin-sensitive Staphylococcus aureus isolate, cultured from an infected cochlear implant, to common antimicrobial agents as well as to novel agents such as tea tree oil. To better simulate in vivo conditions, where bacteria grow as microcolonies encased in glycocalyx, the bactericidal activity of selected antimicrobial agents against the isolate growing in biofilm were also compared., Results: When grown planktonically, the S aureus isolate was susceptible to 17 of the 18 antimicrobials tested. However, when grown in biofilm, it was resistant to all conventional antimicrobials. In contrast, 5 per cent tea tree oil completely eradicated the biofilm following exposure for 1 hour., Conclusion: Treatment of infected cochlear implants with novel agents such as tea tree oil could significantly improve salvage outcome.

Case Presentation: A 46-year-old man suffering from progressive deafness since childhood received a Clarion 90 K cochlear implant with the HiRes preformed electrode in his left ear in October 2006. A persistent Staphylococcus aureus infection failed to be treated with corticoids, amoxicillin/ clavulanate, ciprofloxaxin, and rifampin. The processor was removed on July 2007., Interventions: The removed cochlear implant processor was treated with different reagents, with the aim of detecting a S. aureus and S. aureus biofilm: (1) fluorescein-coupled Fc of anti-human serum, (2) polyclonal anti-polysaccharide intercellular adhesion antibodies coupled to Alexa Fluor 568 goat anti-rabbit immunoglobulin (Ig)G, (3) crystal violet, (4) methylene blue, (5) acridine orange, (6) Gram stain, and (7) live/dead fluorescent stain., Results: S. aureus and the major constituent of the S. aureus biofilm, the polysaccharide intercellular adhesion, were detected on the surface of the implant. S. aureus was isolated after a simple contact between the implant and a solid growth medium. The ability of the isolated S. aureus strain to produce biofilm in vitro was confirmed., Interpretation: S. aureus biofilm was documented on the implant. Initial bacterial colonization could be related to the pocket of the removable magnet. Colonies of S. aureus without biofilm were found attached to the electrode wire., Conclusion: We report one case of a S. aureus biofilm infection documented on a cochlear implant, as assessed by immuno-microscopy. The biofilm was likely responsible for the persistent infection which manifested for many months after the implant surgery and could explain the unusual bacterial phenotypic resistance against administered antimicrobial agents.

Aim: Bone-anchored hearing aids are well established, implanted devices. We present two patients who suffered mixed hearing loss and who underwent titanium implant placement in the temporal bone to enable attachment of bone-anchored hearing aids. Osseointegration is necessary for such implants to function. We report these two cases to highlight how such osseointegration may be disrupted., Method: Attached tissue from the explanted or removed titanium implants was examined by transmission electron microscopy and histopathological analysis., Results: Attached tissue from both implants showed the presence of keratinocytes at the titanium implant and living bone interface. This was confirmed by histopathological analysis. In one case, there was frank keratinocyte proliferation, which had led to osseointegration failure; in the other case, such proliferation was present but not so advanced., Conclusion: These findings suggest that, in the cases reported, keratinocytes implanted between the titanium and the living bone, leading to disruption of osseointegration.

Cochlear implants (CI) represent the "gold standard" for the treatment of congenitally deaf children and postlingually deafened adults. Thus, cochlear implantation is a success story of new bionic prosthesis development. Owing to routine application of cochlear implants in adults but also in very young children (below the age of one), high demands are placed on the implants. This is especially true for biocompatibility aspects of surface materials of implant parts which are in contact with the human body. In addition, there are various mechanical requirements which certain components of the implants must fulfil, such as flexibility of the electrode array and mechanical resistance of the implant housing. Due to the close contact of the implant to the middle ear mucosa and because the electrode array is positioned in the perilymphatic space via cochleostomy, there is a potential risk of bacterial transferral along the electrode array into the cochlea. Various requirements that have to be fulfilled by cochlear implants, such as biocompatibility, electrode micromechanics, and although a very high level of technical standards has been carried out there is still demand for the improvement of implants as well as of the materials used for manufacturing, ultimately leading to increased implant performance. General considerations of material aspects related to cochlear implants as well as potential future perspectives of implant development will be discussed.

Objective: To assess whether free-living and/or biofilm bacteria are present in the putative sterile middle ear cavity before insertion of the electrode array during cochlear implantation., Design: Prospective study., Setting: Tertiary academic hospital., Patients: The study included 45 healthy children (with or without a history of otitis media) undergoing cochlear implantation., Interventions: Transmission electron microscopy or scanning electron microscopy was used to detect the presence of bacteria., Main Outcome Measure: Presence of both free-living bacteria and biofilm bacteria on the epithelial surface of biopsy specimens of middle ear mucosa., Results: A majority of all mucosal specimens from clinically healthy tympanic cavities displayed inflammatory areas as well as dispersed, nonmatrix-enclosed bacteria. Also, rarely, fragments of biofilms were found., Conclusions: The presence of bacteria in the tympanic cavity, which is generally assumed to be sterile in healthy individuals, may provide an explanation for infectious complications after cochlear implantation. However, the possibility that the electrode array of a cochlear implant will actually become contaminated during insertion is unlikely because of the small amounts and dispersed presence of bacteria, which may account for the relatively low incidence of infectious complications after cochlear implantation.

Objective: The aim is to analyze the efficacy of heptavalent conjugate vaccine against Streptococcus pneumoniae (VPn7) in children with cochlear implant, in relation with the eradication of nasopharyngeal carriers and the prevention of complications. Analysis of the antimicrobial resistance and sensitivity of the different pneumococci strains isolated in cochlear implant nasopharyngeal carriers and healthy non-vaccinated children., Method: Pneumococcal nasopharyngeal carriers were analyzed in this prospective study including two groups of children aged between 2 and 5 years, from 2005 to 2006. The first group included 55 cochlear implant recipients and all of them were vaccinated with VPn7. The second group included 60 non-vaccinated healthy children. Nasopharyngeal swabs for culture were obtained from each child in order to detect the pneumococcus, its serotypes and the sensitivity to antibiotics., Results: In the control group of non-vaccinated children, 25% of them were found to be pharyngeal pneumococcus carriers, whereas this figure fell to 11% in the vaccinated group. The non-vaccine serotypes (83.3%) isolated in vaccinated children showed high or moderate sensitivity to penicillin. There were no complications due to S pneumoniae infections in any of the patients with cochlear implant who were vaccinated., Conclusions: VPn7 contributes to a decrease in pharyngeal colonization by pneumococci in general and, in particular, by the pneumococcal serotypes included in the vaccine, although there is a replacement phenomenon involving non-vaccine serotypes.

The restoration of hearing to persons with severely or profoundly impaired hearing by means of a cochlear implant is one of the great achievements of bionics applied to medicine. However, pneumococcal meningitis in implant recipients has received high profile public attention as a result of the US Food and Drug Administration's public health notification and recent media attention. Worldwide, 118 of the 60,000 people who received cochlear implants over the past 20 years have acquired meningitis, causing deep concern in the international medical community. This review provides answers to pediatricians, internists, and infectious diseases doctors who have patients with cochlear implants and who have questions about the safety of the cochlear implant from both the clinical and scientific research perspectives. Both clinical and laboratory research support the notion that pneumococcal meningitis is more likely in patients who receive cochlear implantation, and that the surgical insertion technique and the cochlear implant design should be nontraumatic, and that all cochlear implant recipients should be offered vaccination against Streptococcus pneumoniae.

Objectives: Infectious complications may cause significant delay in cochlear implant device initiation and programming and be a source of additional morbidity. We reviewed our experience with infectious complications in the pediatric age group to determine specific sources that may not be seen in adults., Study Design: A retrospective analysis from a single implant center., Methods: Cases of pediatric cochlear implants were reviewed for data on infectious complications. Complications were identified as "major" or "minor," "early" or "delayed." Information was gathered regarding any comorbid, chronic health condition. Data related to the causative organism(s) were collected., Results: Two hundred sixty-eight cases of pediatric implants were reviewed. Twenty-two cases were identified (an infection rate of 8.2%), all classified as "major." The majority, 12, were classified as "delayed" complications. Twenty-one cases required explantation with 14 successfully reimplanted. Five cases (in 4 patients) or 23% were associated with a specific chronic pediatric condition including two children with tracheostomies. Among implanted children who had chronic health conditions, 42% developed implant-related infections. Among otherwise healthy implanted children, only 6.6% developed implant-related infections. Resistant bacterial infections were not identified., Conclusions: Health conditions in the pediatric age group were associated with 23% of our complications, a risk factor not previously identified in the literature. These children, demonstrating seven times the infection rate of healthy children, should be carefully observed postoperatively. Overall, cochlear implantation in children continues to be associated with a low risk of infectious complications.

Objectives: To examine if a 23-valent pneumococcal capsular polysaccharide vaccine (PPV23) reduces the risk of meningitis in healthy rats after cochlear implantation., Design: Interventional animal study., Interventions: Thirty-six rats (18 immunized and 18 unimmunized) received cochlear implantations and were then infected with Streptococcus pneumoniae via 3 different routes (hematogenous, middle ear, and inner ear) in numbers sufficient to induce meningitis., Results: The rats with implants that received PPV23 were protected from meningitis when the bacteria were delivered via the hematogenous and middle-ear routes (Fisher exact test P<.05). However, the protective effect of the vaccine in the rats with implants was only moderate when the bacteria were inoculated directly into the inner ear., Conclusions: Our animal model clearly demonstrates that immunization can protect healthy rats with a cochlear implant from meningitis caused by a vaccine-covered serotype. This finding supports the notion that all current and future implant recipients should be vaccinated against S pneumoniae.

Background: Biofilms present a new challenging concept in sustaining chronic, common antibiotic-resistant ear, nose, and throat (ENT) infections. They are communities of sessile bacteria embedded in a matrix of extracellular polymeric substances of their own synthesis that adhere to a foreign body or a mucosal surface with impaired host defense. The aim of this paper is to review the literature on ENT diseases that can be attributed to biofilm formation and to discuss options for future treatment., Materials and Methods: Literature review from Medline and database sources. Electronic links and related books were also included., Study Selection: Controlled clinical trials, animal models, ex vivo models, laboratory studies, retrospective studies, and systematic reviews., Data Synthesis: Biofilm formation is a dynamic five-step process guided by interbacterial communicating systems. Bacteria in biofilms express different genes and have markedly different phenotypes from their planktonic counterparts. Detachment of cells, production of endotoxin, increased resistance to the host immune system, and provision of a niche for the generation of resistant organisms are biofilm processes that could initiate the infection process. Effective prevention and management strategies include interruption of quorum sensing, inhibition of related genes, disruption of the protective extrapolymer matrix, macrolides (clarithromycin and erythromycin), and mechanical debridement of the biofilm-bearing tissues. With regard to medical indwelling devices, surface treatment of fluoroplastic grommets and redesign of cochlear implants could minimize initial microbial colonization., Conclusion: As the role of biofilms in human infection becomes better defined, ENT surgeons should be prepared to deal with their unique and tenacious nature.

We discuss the diagnostic value of nuclear scintigraphy in the management of infections after cochlear implantation. A 56-year-old female (Case 1) and a 46-year-old female (Case 2) developed complaints of diffuse headache, 4 and 5 months after cochlear implantation, without other signs of infection during examination, laboratorial testing and initial computed tomography. In Case 1 we performed a technetium 99 m-difosfate scintigraphy, which showed an increased uptake in the right petrosal bone, suggestive of chronic osteomyelitis. This case failed conservative treatment and underwent complete explantation, after which 67gallium-citrate single-photon emission computed tomography normalized during follow-up. In Case 2 inflammation at the site of the cochlear implant was confirmed by performing a positron emission tomography scan, which showed an increased uptake. Case 2 was treated successfully with antibiotics. Both have no signs of recurrent infection. Nuclear scintigraphy can be the single valuable tool in case of a late low-grade infection after cochlear implantation. Delayed low-grade chronic osteomyelitis of the petrosal bone is a rare but dramatic complication after cochlear implantation. It can develop with minimal signs of infection.

Objective: To report the characteristics of a bacterial biofilm from the surface of a cochlear implant., Background: Bacterial biofilm formation on implanted devices causes intractable infections and device extrusions necessitating device removal, with loss of function. More information is needed about biofilm characteristics and interactions with the implant surface before better treatments can be designed., Study Design: A retrospective case review was combined with a descriptive histological study of the surface of an otologic device., Methods: The receiver/stimulator device removed from a cochlear implant patient because of intractable infection and partial device extrusion was fixed and processed for microscopic examination. Its surface and the material present on its surface were analyzed using light and electron microscopy, focusing on surface texture, cell types, and bacteria species and extracellular polymeric substances present within the biofilm., Results: Stereomicroscopic examination revealed extracellular polymeric substances, pinkish yellow in color, with spheres of uniform size scattered throughout, indicative of a biofilm containing Staphylococcus aureus. Biofilm density was greatest in depressions on the surface of the implant. Cross-sectional analysis revealed bacteria interspersed with polymorphonuclear leukocytes. Scanning electron microscopic examination demonstrated an amorphous layer of extracellular polymeric substances containing small filaments, bacteria, and inflammatory cells. Only Staphylococcus aureus was detected., Conclusion: Cochlear implant material can provide a surface for bacterial biofilm formation. Impressions can provide an environment conducive to biofilm establishment and growth, ultimately necessitating device removal, with loss of implant function. Biofilm characterization should aid in design of cochlear implant devices less susceptible to biofilm formation.

In recent years there has been increasing interest in the role of biofilms in perpetuating the chronicity and severity of bacterial infections. Enter the word biofilm as a search criterion with PubMed (National Library of Medicine) and you will doubtless be surprised to recover over 4000 citations, with nearly 3000 registered since 2000. So why has there been such an explosion of interest in this phenomenon? This article seeks to provide a brief overview of the subject, with particular reference to the role that biofilms may have to play in otologic disease.

Unlabelled: The following paper provides an overview of public health research at the Centers for Disease Control and Prevention (CDC), with emphasis on research involving speech, language and hearing disorders. Public health research involves a sequence of activities from disease tracking to disease prevention. Public health focuses on populations and works to identify changes in programs and policies that can positively impact population health. This paper uses three recent studies conducted by CDC investigators to illustrate different types of research along the public health prevention continuum, with emphasis on activities involving speech, language, and hearing endpoints. The three examples are: a study of cochlear implants and the subsequent risk of meningitis (illustrative of a public health response); a study examining the prevalence of autism in several U.S. populations (an example of a surveillance or monitoring activity); and a study examining the role of in utero cigarette exposure in the etiology of oral facial clefts (illustrative of a epidemiologic risk factor study). The public health continuum provides an important vehicle for advancing our knowledge of the causes and effective prevention of communication disorders., Learning Outcomes: The reader will become familiar with the public health sequence and the manners in which public health research relates to speech, language, and hearing disorders. The reader will be able to identify and discriminate among the components of public health research using the examples provided.

Background: During 2002, there was an increase in reports of bacterial meningitis among people with cochlear implants in Europe and North America. One model of implant, which included a space-occupying 'positioner', was recalled. Implantation of a positioner was shown to be a risk factor for meningitis among children in the United States. The situation in the United Kingdom was not known., Methods: We ascertained the cohort of people who had received cochlear implants with intra-cochlear electrodes in UK hospitals prior to 1 October 2002 and were permanently resident in the United Kingdom. We compared the incidence of meningitis, and the causes and incidence of death from all causes, between the cohort and reference populations., Results: Of 1851 children (66 with positioners), none had contracted meningitis. Neither the incidence rate of meningitis, nor the cumulative mortality from all causes, differed significantly between implanted children and values expected for the general population. Of 1779 adults (139 with positioners), five had contracted meningitis with three fatalities. No case of meningitis involved a positioner and four of the cases, including the fatalities, possessed risk factors unrelated to implantation. Although the incidence rate of meningitis was significantly higher in implanted adults than the general population, cumulative mortality from all causes was never higher, and was significantly lower at some time points after implantation., Conclusion: Specific evidence of the association between bacterial meningitis and implantation with a positioner that arose in the United States and mainland Europe during 2002 has not been found in the United Kingdom.

Objective: To discuss chronic, refractory Pseudomonas infections of cochlear implants and their management., Design: Retrospective case series., Setting: Two university-based cochlear implant programs., Patients: Twenty-eight-year-old (Case 1) and 4-year-old (Case 2), different devices., Interventions: Medical and surgical management., Main Outcome Measures: Clinical course., Results: Both patients had delayed presentations, 4 months and 3 years postimplantation, respectively, with fluctuating scalp edema and pain resistant to multiple courses of oral antibiotics. Infections began as localized granulation and progressed to complete encasement of both devices with rubbery, poorly vascularized tissue. In each case, two different strains of multiresistant Pseudomonas aeruginosa were cultured. Infections progressed despite local debridement and targeted antipseudomonal antibiotic coverage, and sensitive organisms continued to appear in cultures of refractory granulation tissue. Both patients underwent partial explantation, with the electrode array left in the cochlea, then received 2 to 3 more months of further medical therapy and observation and then were reimplanted successfully with new devices. Both have shown excellent performance and no sign of recurrent infection., Conclusions: Infections of cochlear implants are uncommon, and cases of successful conservative management without device explantation have been reported. However, our experience and the implanted device literature suggest that chronic Pseudomonas infections may represent a distinct clinical entity, likely to fail protracted therapy and ultimately require device removal. Fortunately, successful reimplantation is possible.

Objectives: To determine if bacterial biofilms are present on the surface of extruding or persistently infected cochlear implants., Methods: Scanning electron microscopy was performed on cochlear implants removed from two patients because of recalcitrant infection, two implants removed secondary to device failure, and two devices that had never been implanted. Preparations were examined by experienced microbiologists for the presence of bacterial biofilms., Results: Microorganisms and amorphous extracellular debris were found on the surface of the infected cochlear implants and the implants removed because of device failure. Biofilm formation was deemed definite in one infected device and possible in the other explanted devices. The never-implanted controls demonstrated microbial contamination without exopolymeric matrix, inconsistent with biofilms., Conclusion: Bacterial biofilm formation may play a role in recalcitrant cochlear implant infections. This may have profound implications for the treatment of cochlear implant infections.

Cochlear implantation in patients with chronic suppurative otitis media is managed with perioperative antibiotics; however, fungal overgrowth can occur. We present a child who received oral cefdinir and topical ofloxacin (Floxin). After 6 weeks, a fungal (Candida) biofilm was demonstrated on the implant surface. In this clinical setting, an antimicrobial strategy using an oral antifungal to prevent fungal overgrowth is a possibility.

Objective: Recently, the association of meningitis with cochlear implants has raised concern over the safety of these devices. We examined the incidence of all postoperative infections in patients undergoing cochlear implant surgery. Study design and settings A retrospective chart review of all patients undergoing cochlear implants at a private tertiary referral center from 1993 to 2002 was performed. Cochlear implant surgeries in 462 adults and 271 children were reviewed. Patients with evidence of a postoperative infection or infectious complication related to cochlear implantation were identified, and data on patient characteristics, surgery, and treatment outcome were obtained., Results: The overall incidence of postoperative infection in our cochlear implant series was 4.1%. Major infectious complications occurred in 3.0% of cases, and the majority of infections required surgical intervention. A history of chronic ear disease may increase the risk of infectious complications. There were no cases of meningitis., Conclusions: Cochlear implants remain a safe procedure with a low complication rate. The majority of infections can be managed without removing the implant device. Advances in surgical technique and flap design have decreased the occurrence of wound-related complications. However, identification of risk factors for infection and optimization of treatment regimens will further reduce the complications associated with postoperative infection.

Objective: Cochlear implantation has become a routine operation in the last 10 years. The most common soft tissue complications with transcutaneous cochlear implants include infection or necrosis of the flap and extrusion of the implant and device failure. The most common complication reported with percutaneous devices include minor skin irritations at the pedestal site, retraction of skin from the pedestal site, and loosening of screws that retain the pedestal. We describe one case of lateral sinus thrombosis and secondary temporal lobe infarction caused by infection of a screw anchoring the percutaneous pedestal of an Ineraid implant., Study Design: Case report., Setting: Tertiary referral center., Conclusions: Intracranial complications of a percutaneous bone-anchored pedestal may occur with little prodrome. Computed tomography (CT) scan of the pedestal and bone anchoring screws may be indicated if local evidence of infection persists.